Zelnorm (tegaserod) Lawsuit & News Blog

Zelnorm Production Halted in China

Thu, 14 Jun 2007 14:30:15 -0400

Following the example of the United States, health regulators in China have issued an order to withdraw Novartis' irritable bowel syndrome drug Zelmac from the market.

The country's State Food and Drug Administration said it had made the decision because the risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad. China's move comes in the wake of similar decisions taken in the USA and more recently in Switzerland where sales of the drug have been suspended amid fears of cardiovascular risk.

Zelnorm has been available in China since 2003 and the country's National Centre for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions, notably diarrhea and nausea. One case of tachycardia was reported, as were two concerning heart palpitations and one case of low blood pressure.

Source: http://www.pharmatimes.com/WorldNews/Articles/11038-china-zelnorm.aspx?src=PTArchive

Mother Demands Zelnorm: Will Take the Risk

Tue, 1 May 2007 09:48:01 -0400

http://www.myfoxwghp.com/myfox/pages/News/Detail?contentId=3038242&version=3&locale=EN-US&layoutCode=TSTY&pageId=3.2.1

What's a mother to do when Zelnorm is recalled? The North Carolina woman says that Zelnorm is the only drug that has helped her 22-year-old son with his rare gastrointestinal problems or weight loss and vomiting.

The mother called Novartis to ask for a special prescription waiver but they said it would take months to pass through the FDA bureaucracy and the mother feels her son cannot wait.

Alternative Drug to Zelnorm

Mon, 30 Apr 2007 09:45:53 -0400

Alternative Drug to Zelnorm - http://www.pharmalive.com/News/index.cfm?articleid=435237&categoryid=10

Kristalose is a prescription laxative product that treats acute and chronic constipation. Constipation is a common disorder affecting approximately 20 percent of the U.S. population.

Kristalose may be an effective alternative for some patients previously treated with Zelnorm. Marketing of Zelnorm was suspended recently after new data showed that a statistically significant number of cardiovascular problems occurred in patients taking Zelnorm since it was approved in 2004.

Kristalose Oral Solution is a proprietary prescription laxative and the brand name for a unique crystalline form of lactulose. Available in pre-dosed packets, the drug dissolves quickly in four ounces of water, offering patients a virtually tasteless and grit-free alternative to other liquid lactulose treatments. Initial dosing may produce flatulence and intestinal cramps, which usually go away.

Lawyers Seek FDA Zelnorm Documents through Freedom of Information Act

Fri, 20 Apr 2007 06:13:29 -0400

The law firm of Anapol Schwartz Weiss Cohan Feldman & Smalley has filed a request (FOIA request to FDA.pdf) with the Food and Drug Administration (FDA) under the Freedom of Information Act (FOIA, 5. U.S.C. 552) seeking documents and records as they pertain to the Novartis Pharmaceuticals Corporation’s drug Zelnorm (tegaserod maleate). In particular the request seeks those documents that lead the FDA to request that Novartis cease marketing Zelnorm.

FDA Announces Discontinued Marketing of IBS-Constipation Drug Zelnorm

Wed, 11 Apr 2007 12:12:29 -0400

http://www.medicalnewstoday.com reports that The Food and Drug Administration (FDA) has requested that the New Jersey pharmaceutical company, Novartis, voluntarily discontinue marketing Zelnorm. Recent findings discovered an increased risk of serious heart problems from using Zelnorm. Novartis has agreed to voluntarily suspend marketing of the drug in the United States; it is marketed in 55 countries. What will the other 54 countries do?

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. Zelnorm was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65.

FDA is currently advising patients who are using Zelnorm to contact their healthcare providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

In a recent clinical study of 11,600 patients treated with Zelnorm and over 7,000 patients treated with a placebo, data showed that there was a higher risk of serious adverse heart events such as angina, heart attacks, and strokes associated with Zelnorm than with placebo treatment.

Irritable Bowel Syndrome (IBS) Facts 101

Tue, 10 Apr 2007 12:16:32 -0400

http://www.medicalnewstoday.com/medicalnews.php newsid=67338 reports that IBS is an often painful disorder of the lower intestine that causes cramping, abdominal pain, bloating, constipation, and diarrhea. IBS affects 10 to 15 percent of the U.S. population. Because not all sufferers have the same symptoms nor are they affected by the same foods which makes IBS difficult to diagnose.

IBS is not psychosomatic. Though stress may worsen IBS, it's not the primary cause. IBS affects both men and women, although for some unknown more women than men suffer from IBS. The elderly among the many ills suffer less from IBS than their younger counterparts. Although IBS is not life threatening, it can greatly impact a person's quality of life. Lactose intolerance does not affect IBS. There are certain trigger foods that may affect IBS which is why keeping a food journal is so important. Not also IBS sufferers need to remain on a bland diet for life.

IBS is not that difficult to diagnose if the doctor is listening and the patient is paying attention and being honest about the symptoms. IBS can be affectively managed with over the counter and prescription medications.

Biofeedback may relieve chronic constipation

Sun, 8 Apr 2007 12:19:55 -0400

Biofeedback training can be useful for people with a type of chronic constipation characterized by excessive straining, anal contraction, and impaired propulsion of stool from the rectum. Laxative treatment long-term fails.

About a third of people with chronic constipation seen in specialized centers have this type of constipation. They conducted a study to see if the condition could be relieved by biofeedback focusing on anal muscle relaxation and coordination and simulated defecation training.

They randomized 77 subjects to about six hours in one hour-therapy sessions. At three months, results were much better in the active biofeedback group than the other two groups. The number of complete spontaneous bowel movements showed a significantly greater increase in the active biofeedback group than in the sham or standard groups. The movement of waste material through the colon improved significantly after biofeedback or standard therapy. (See: http://news.yahoo.com/s/nm/20070409/hl_nm/biofeedback_constipation_dc_1)

Novartis Ceases Zelnorm Marketing in America

Sat, 7 Apr 2007 12:22:46 -0400

Novartis AG, Switzerland's largest drug maker, stopped U.S. sales of its Zelnorm irritable bowel syndrome treatment at the request of the Food and Drug Administration after people taking the medicine had more heart attacks and strokes.

A review of data from 18,000 patients showed that a statistically significant number had heart problems and one patient died.
Zelnorm brought in $488 million in the U.S. in 2006, where about 500,000 people are taking the product. Sales are suspended in Canada, and Novartis is talking to health agencies in other countries. The drug will stay on the market in Switzerland.

Last year, the medicine was rejected for a second time by a European Union health advisory panel. The risks of Zelnorm outweighed the possible benefits.

See: http://www.bloomberg.com/apps/news?pid=20601103&sid=a41duwScFn0Y

Zelnorm Precautionary Labeling - 2004

Wed, 4 Apr 2007 18:37:15 -0400

April 28, 2004-Specific Zelnorm labeling revisions include a new warning about the serious consequences of diarrhea associated with the medication; a new precaution about ischemic colitis and other forms of intestinal ischemia (i.e., reduced blood flow to the intestines); changes to the adverse reactions section describing post-marketing reports; and new information in the "Information for the Patient" leaflet.

The new warning states, "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea.

Zelnorm Recall Will Affect Thousands

Tue, 3 Apr 2007 18:38:51 -0400

According to the FDA, the risks outweigh the benefits. Clinical studies revealed that out of 11,000 people taking Zelnorm - 13 had heart attacks.

For now the FDA said it will consider reintroducing Zelnorm on a limited basis after more testing. Novartis will offer a refund to any unused or expired pills.